Qvar vs FP in Pediatrics

NCT ID: NCT01877954

Last Updated: 2013-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2654 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-03-31

Brief Summary

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The primary aim of this study was to compare the absolute and relative effectiveness of asthma management in paediatric patients in the UK on inhaled corticosteroid (ICS) maintenance therapy as extra-fine HFA-BDP (Qvar®) pressurised metered dose inhaler (pMDI) compared with fluticasone propionate (FP) pMDI.

Detailed Description

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Comparison of asthma control with extrafine-particle hydrofluoroalkane-beclometasone (EF HFA-BDP) vs fluticasone propionate (FP) in paediatric patients (5-11year olds). Patients identified from the General Practice Research Database (GPRD) and the Optimum Patient Care Research Database (OPCRD). Two analyses were conducted:

1. Comparison of outcomes achieved by EF HFA-BDP and FP in 5-6year old patients with those achieved in 7-11yr old patients.
2. Comparison of outcomes achieved by EF HFA-BDP used with or without a spacer to those achieved by standard particle fluticasone propionate (FP) used with a spacer.

Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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IPDI Qvar

ICS initiation as Extra-fine hydrofluoroalkane beclometasone dipropionate

Extra-fine hydrofluoroalkane beclometasone dipropionate

Intervention Type DRUG

IPDI FP

ICS initiation as fluticasone propionate

Fluticasone propionate

Intervention Type DRUG

Interventions

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Extra-fine hydrofluoroalkane beclometasone dipropionate

Intervention Type DRUG

Fluticasone propionate

Intervention Type DRUG

Other Intervention Names

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Qvar®

Eligibility Criteria

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Inclusion Criteria

1. Aged: 5-11 years
2. Evidence of asthma (diagnostic code and/or current asthma therapy);
3. Have at least one year of up-to-standard (UTS) baseline data (during which the step-up to FP/SAL occurred) and at least one year of UTS outcome data (following the IPD).

Exclusion Criteria

1. Had any chronic respiratory disease, except asthma, at any time; and/or
2. Patients on maintenance oral steroids during baseline year
Minimum Eligible Age

5 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role collaborator

Research in Real-Life Ltd

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Price

Role: PRINCIPAL_INVESTIGATOR

Research in real life

References

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Leach CL, Davidson PJ, Hasselquist BE, Boudreau RJ. Influence of particle size and patient dosing technique on lung deposition of HFA-beclomethasone from a metered dose inhaler. J Aerosol Med. 2005 Winter;18(4):379-85. doi: 10.1089/jam.2005.18.379.

Reference Type BACKGROUND
PMID: 16379614 (View on PubMed)

Leach CL, Davidson PJ, Boudreau RJ. Improved airway targeting with the CFC-free HFA-beclomethasone metered-dose inhaler compared with CFC-beclomethasone. Eur Respir J. 1998 Dec;12(6):1346-53. doi: 10.1183/09031936.98.12061346.

Reference Type BACKGROUND
PMID: 9877489 (View on PubMed)

Giraud V, Roche N. Misuse of corticosteroid metered-dose inhaler is associated with decreased asthma stability. Eur Respir J. 2002 Feb;19(2):246-51. doi: 10.1183/09031936.02.00218402.

Reference Type BACKGROUND
PMID: 11866004 (View on PubMed)

Newman SP, Weisz AW, Talaee N, Clarke SW. Improvement of drug delivery with a breath actuated pressurised aerosol for patients with poor inhaler technique. Thorax. 1991 Oct;46(10):712-6. doi: 10.1136/thx.46.10.712.

Reference Type BACKGROUND
PMID: 1750017 (View on PubMed)

Newman SP, Millar AB, Lennard-Jones TR, Moren F, Clarke SW. Improvement of pressurised aerosol deposition with Nebuhaler spacer device. Thorax. 1984 Dec;39(12):935-41. doi: 10.1136/thx.39.12.935.

Reference Type BACKGROUND
PMID: 6440305 (View on PubMed)

Chrystyn H, Price D. Not all asthma inhalers are the same: factors to consider when prescribing an inhaler. Prim Care Respir J. 2009 Dec;18(4):243-9. doi: 10.4104/pcrj.2009.00029.

Reference Type BACKGROUND
PMID: 19513494 (View on PubMed)

Price D, Thomas M. Breaking new ground: challenging existing asthma guidelines. BMC Pulm Med. 2006 Nov 30;6 Suppl 1(Suppl 1):S6. doi: 10.1186/1471-2466-6-S1-S6.

Reference Type BACKGROUND
PMID: 17140424 (View on PubMed)

Price D, Martin RJ, Barnes N, Dorinsky P, Israel E, Roche N, Chisholm A, Hillyer EV, Kemp L, Lee AJ, von Ziegenweidt J, Colice G. Prescribing practices and asthma control with hydrofluoroalkane-beclomethasone and fluticasone: a real-world observational study. J Allergy Clin Immunol. 2010 Sep;126(3):511-8.e1-10. doi: 10.1016/j.jaci.2010.06.040. Epub 2010 Aug 9.

Reference Type RESULT
PMID: 20692026 (View on PubMed)

Other Identifiers

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R02511

Identifier Type: -

Identifier Source: org_study_id

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